Fondaparinux (Arixtra) With Chemotherapy for Advanced Non-Small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Venous Thromboembolism

In brief

There is a direct association between cancer and thrombosis (blood clots). The purpose of this study is to determine the best dose of an antithrombotic (prevents blood clots) agent called fondaparinux in non-small cell lung cancer(NSCLC). Patients will also receive chemotherapy.

Key facts

Study ID

NCT00476216

Run by

University of Alabama at Birmingham

People needed

23

Starts

2007-09-01

Expected to finish

2013-12-01

Last updated by the study team

2014-03-05

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic or cytologic diagnosis of Non-Small Cell Lung Cancer.
• Stage IV Non-Small Cell Lung Cancer.
• Measurable or assessable tumor parameters according to RECIST criteria.
• ECOG Performance Status 0-2.
• Age between 18 and 79 years (in the State of Alabama > 18).
• Adequate hematologic, coagulation, liver and renal function, defined as:
• Absolute neutrophil count (ANC) ≥ 1500/µL
• Platelet count ≥ 100,000/µL
• Serum Glutamic Oxaloacetic Transaminase(SGOT)/Serum Glutamic Pyruvic Transaminase(SGPT) ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal when liver metastases are present
• Total bilirubin value ≤ 1.5 x upper limit of normal
• Serum creatinine value ≤ 1.5 x upper limit of normal
• Normal prothrombin time and partial thromboplastin time
• Fully recovered from any previous surgery (at least 4 weeks since major surgery).
• Must have recovered from prior radiation therapy (at least 3 weeks).
• All participants must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential.
• Must provide written informed consent and authorization to use and disclose health information.
• No prior chemotherapy.

You may not qualify if…

• Active bleeding disorder.
• Evidence of hemoptysis. Patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator.
• Previous history of Venous Thromboembolism (VTE) within 12 months and requiring active anticoagulation therapy.
• Concurrent cancer chemotherapy, biologic therapy or radiotherapy.
• Administration of any investigational drug within 28 days prior to administration of the current therapy.
• Symptomatic brain metastases; those patients should be treated first with either whole brain radiation therapy or radiosurgery and have stable disease.
• Concurrent serious infection.
• Concomitant severe or uncontrolled underlying medical disease unrelated to the tumor, which is likely to compromise patient safety and affect the outcome of the study.
• History of other malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for a minimum of 2 years.
• Any evidence or history of hypersensitivity or other contraindications for the drugs used in this trial.
• Psychiatric disorder that prevents patients from providing informed consent or following protocol instructions.
• Pregnant or lactating women.
• Creatinine clearance < 30 mL/min.
• Patient body weight < 50 kg.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.